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Quality of Life in Advanced Colorectal Cancer

University Hospital and Centre Alexis Vautrin, Vanduvre-lès-Nancy, France

To the Editor: We read with great interest the recent article by Köhne et al¹ in the Journal of Clinical Oncology. The authors described the results of a trial with 236 patients with advanced colorectal cancer (ACC) randomized to receive high-dose fluorouracil (5-FU) weekly as a 24-hour infusion, combined with either folinic acid (arm A), interferon alfa-2b (arm B), or both modulators. Because of toxicity, mainly grade 4 diarrhea, reduction of the 5-FU dose by 20% was necessary in the three arms during the first or second cycle. The response rate was significantly higher for patients who received arm A (44%), especially in patients without previous adjuvant chemotherapy (48%). The median survival time for all patients was 15.1 months. A good result may be due in part to the selection of patients: 95% of the patients had Karnofsky performance status 80 to 100 at inclusion. Unfortunately, the article contains no data on quality of life (QL), although QL was measured in this study using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), according to results presented at different meetings.^2,3 In an interim analysis based on the results of 194 patients, none of the 15 dimensions of QL improved during the course of treatment in any of the three study arms. The authors reported a significant deterioration of the following dimensions at week 8: physical functioning (arms B and C), social functioning (arm C), role functioning (arms A, B, and C) and global QL (arms A and C). Symptoms (anorexia, fatigue, nausea/vomiting, and diarrhea) worsened in all arms.

To our knowledge, these are the first data indicating that 5-FU–based chemotherapy can deteriorate QL. Until now, literature has indicated that palliative chemotherapy in patients with ACC maintains or improves QL. Three randomized studies comparing chemotherapy and best supportive care have concluded that chemotherapy improves survival with maintained QL.^4-6 Data from at least eight prospective studies indicate that a high proportion (27% to 56%) of patients treated with chemotherapy have improved QL.⁷ Improvement of QL was also recently proven with irinotecan as second-line chemotherapy in comparison to best supportive care.⁸ However, these studies included a mixture of symptomatic and asymptomatic patients. Asymptomatic patients are more likely than those with symptoms to show reduced QL because of the toxicity of therapy. This may be the case in the present study with high-dose infusional 5-FU. Moreover, the EORTC QLQ-C30 asks patients about the previous week, and patients receiving weekly treatment are more likely to report symptoms and toxicities. However, the weekly administration of chemotherapy has been associated with decreased QL in randomized studies compared with 3-times-a-week treatment in other tumors, such as breast cancer and small-cell lung cancer.^9-11 QL seems to be an essential efficacy end point usefully supplementing toxicity outcome. We hope that the complete QL data will be published in another article, and we regret that the patients' point of view was not taken into account in this report.

REFERENCES

1. Köhne CH, Schöffski P, Wilke H, et al: Effective biomodulation by leucovorin of high-dose infusion fluorouracil given as a weekly 24-hour infusion: Results of a randomized trial in patients with advanced colorectal cancer. J Clin Oncol 16:418-426, 1998[Abstract]

2. Schöffski P, Köhne CH, Schellenberger U, et al: Does effective chemotherapy metastatic colorectal cancer (CC) improve quality of life (QL): Preliminary results of a randomized phase II-study using the EORTC QLQ C30. Eur J Cancer 31A:S62, 1995 (suppl 5)

3. Schöffski P, Schellenberger U, Köhne CH, et al: Quality of life predicts for both response and survival in patients treated for metastatic colorectal cancer: Results of a randomized phase II study. Proc Am Soc Clin Oncol 15:213a, 1996 (abstr)

4. Allen-Mersh TG, Earlam S, Fordy C, et al: Quality of life and survival with continuous hepatic-artery floxuridine infusion for colorectal liver metastases. Lancet 344:1255-1260, 1994[Medline]

5. Glimelius B, Graf W, Hoffman K, et al: General condition of asymptomatic patients with advanced colorectal cancer receiving palliative chemotherapy. Acta Oncol 31:645-651, 1992[Medline]

6. Scheithauer W, Rosen H, Kornek G-V, et al: Randomized comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer. Br Med J 306:752-755, 1993

7. Camilleri-Brennan J, Steele RJC: Quality of life after treatment for rectal cancer. Br J Surg 85:1036-1043, 1998[Medline]

8. Cunningham D, Pyrhönen S, James RD, et al: A phase III multicenter randomized study of CPT-11 versus supportive care (SC) alone in patients (Pts) with 5FU-resistant metastatic colorectal cancer (MCRC). Proc Am Soc Clin Oncol 17:1a, 1998 (abstr 1)

9. Richard MA, Hopwood P, Ramirez AJ, et al: Doxorubicin in advanced breast cancer: Influence of schedule on response, survival and quality of life. Eur J Cancer 28A:1023-1028, 1992

10. Fetting JH, Gray R, Fairclough DL, et al: Sixteen-week multidrug regimen versus cyclophosphamide, doxorubicin, and fluorouracil as adjuvant therapy for node-positive, receptor-negative breast cancer: An Intergroup study. J Clin Oncol 16:2382-2391, 1998[Abstract]

11. Gower NH, Rudd RM, Ruiz de Elvira MC, et al: Assessment of "quality of life" using a daily diary card in a randomised trial of chemotherapy in small-cell lung cancer. Ann Oncol 6:575-580, 1995[Abstract/Free Full Text]

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